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On Tech Ethics with CITI Program
Discusses a broad range of technology ethics topics. Hosted by Daniel Smith, Associate Director of Content and Education at CITI Program. New episodes every month. Learn more at about.citiprogram.org.
On Tech Ethics with CITI Program
Modernizing Clinical Trials with ICH E6(R3) - On Tech Ethics
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CITI Program
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Season 1
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Episode 32
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Discusses the updated International Council for Harmonisation (ICH) Guideline for Good Clinical Practice known as E6(R3) and what it means for researchers.
Our guest today is Cindy Gates, JD, RN, an experienced leader in human subjects research protections and clinical research. Cindy has previously worked at WIRB, the University of California Davis, the University of Miami, the Houston Methodist Medical Center, and George Washington University.
This episode is co-hosted by Eric D. Kupferberg, PhD, Associate Director of Clinical Research Education at CITI Program.
Additional resources:
- ICH E6(R3): https://www.ich.org/page/efficacy-guidelines#6-2
- CITI Program’s ICH E6(R3): An Introduction course: https://about.citiprogram.org/course/ich-e6r3-an-introduction/
Introduction to the Episode
Eric’s Background
Introduction of Cindy Gates
Purpose of ICH Guidelines
Reasons for GCP Update
ICH Guidelines Legal Standing
New Responsibilities for Researchers
Changes in Informed Consent
Investigational Product Management
Data Governance in E6(R3)
Impact of E6(R3) Updates
Resources for Learning About E6(R3)
Final Thoughts on E6(R3)
